The FDA has given clearance for a Phase I/II clinical trial of Hollis-Eden's investigational compound Neumune, which combats healthcare-associated (nosocomial) infections.
The aim of the trial is to establish the safety of Neumune and to help identify the optimal patient subsets for further study in Phase II efficacy trials, said the company.
Healthcare-associated infections present a major problem for patients who are immune suppressed as a result of illness, injury, advanced age or the stress of hospitalization. Approximately 2 million people contract healthcare-associated infections each year in the U.S., leading to an estimated 90,000 deaths annually. Due to the emergence of drug resistant strains of bacteria, many hospital infections can no longer be treated effectively with common antibiotics. In the U.S. alone, the healthcare costs associated with these infections exceed $4.5 billion annually, said the company.